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Ibuprofen

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Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 9, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Ibuprofen 200 mg
Other brand names
Drug class
Nonsteroidal Anti-inflammatory Drug
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 9, 2017
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
ANDA079174
NDC root
51013-319
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

CVS Ibuprofen Tablets USP, 200 mg, are a type of medication designed to provide temporary relief from minor aches and pains. This includes discomfort from headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. Additionally, these tablets can help reduce fever, making them a versatile option for managing various mild to moderate pain and fever symptoms.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including headaches, muscular aches, arthritis pain, toothaches, backaches, the common cold, and menstrual cramps. Additionally, it can help reduce fever for a short period.

This medication is designed to provide you with quick relief from discomfort, making it easier to go about your daily activities. Always remember to follow the recommended guidelines for use to ensure safety and effectiveness.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 to 6 hours as needed while you have symptoms. If you find that 1 tablet isn’t enough to relieve your pain or fever, you may take 2 tablets instead. However, it’s important not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years old, it’s best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important not to use it right before or after heart surgery, as this could pose serious risks to your health.

Be cautious about the dosage; using more than directed or for longer than recommended can increase your risk of heart attack or stroke. Always follow the instructions provided to ensure your safety and well-being.

Side Effects

Ibuprofen can cause serious allergic reactions, particularly in individuals who are allergic to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, this medication carries a risk of severe stomach bleeding, especially for those over 60, with a history of stomach ulcers or bleeding, or who consume alcohol regularly. The risk of heart attack and stroke may also increase with the use of ibuprofen, particularly if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult a doctor if you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. It's important to seek medical advice if you have a history of stomach issues, high blood pressure, heart disease, or if you are taking other medications, especially aspirin, as ibuprofen may interfere with its effectiveness.

Warnings and Precautions

Ibuprofen can cause serious allergic reactions, especially if you are allergic to aspirin. Symptoms may include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters. If you experience any of these symptoms, stop using ibuprofen immediately and seek medical help.

This medication can also lead to severe stomach bleeding, particularly if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than recommended. Additionally, using ibuprofen increases the risk of heart attack and stroke, especially if taken in higher doses or for extended periods.

You should stop using ibuprofen and consult your doctor if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or if your stomach pain worsens or lasts more than 10 days. If you experience any new symptoms, it's important to reach out to your healthcare provider. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

Taking too much ibuprofen can be very harmful. If you or someone you know has taken an overdose, you might notice symptoms such as nausea (feeling sick), vomiting, stomach pain, drowsiness (feeling unusually sleepy), headache, or confusion. In more serious situations, an overdose can lead to kidney failure, liver damage, or gastrointestinal bleeding (bleeding in the stomach or intestines).

If you suspect an overdose, it’s crucial to seek immediate medical attention. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in the outcome. Always remember to use medications as directed to avoid these risks.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication, including ibuprofen. This is particularly crucial during the last three months of pregnancy, as using ibuprofen at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptoms. If one tablet does not relieve pain or fever, you may give 2 tablets, but be sure not to exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, you may have a higher chance of experiencing severe stomach bleeding. This is something to discuss with your healthcare provider, especially if you are taking medications that can affect your stomach.

Additionally, using more medication than recommended or for a longer period than advised can increase your risk of heart attack or stroke. This is particularly relevant for older adults, so it's crucial to follow your doctor's instructions carefully and communicate any concerns you may have about your treatment. Always prioritize your health and safety by staying informed and seeking guidance when needed.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you take ibuprofen, it may reduce the effectiveness of aspirin, especially when aspirin is used to prevent heart attacks or strokes. Additionally, if you are on blood thinners (medications that help prevent blood clots) or steroids, the risk of stomach bleeding can increase when taking ibuprofen.

Moreover, using ibuprofen in higher doses or for longer than recommended can raise your risk of having a heart attack or stroke. Always discuss your current medications and any potential interactions with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° and 25°C (68° to 77°F). This range is considered a controlled room temperature according to the United States Pharmacopeia (USP). It's important to avoid exposing the product to excessive heat, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations. By taking these precautions, you can help ensure the product remains safe and effective for use.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using ibuprofen during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery.

FAQ

What is CVS Ibuprofen Tablets used for?

CVS Ibuprofen Tablets temporarily relieve minor aches and pains due to headaches, muscular aches, arthritis, toothaches, backaches, the common cold, and menstrual cramps. It also temporarily reduces fever.

What should I do if I experience stomach bleeding?

Stop using CVS Ibuprofen and seek medical help if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

How should adults and children 12 years and older take CVS Ibuprofen?

Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, you may take 2 tablets, but do not exceed 6 tablets in 24 hours unless directed by a doctor.

Are there any warnings associated with CVS Ibuprofen?

Yes, CVS Ibuprofen may cause severe allergic reactions, stomach bleeding, and increase the risk of heart attack or stroke, especially if used more than directed or for longer than directed.

Can I use CVS Ibuprofen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use it during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have an allergic reaction to CVS Ibuprofen?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using CVS Ibuprofen and seek emergency medical help immediately.

What are the storage conditions for CVS Ibuprofen?

Store CVS Ibuprofen between 20° – 25°C (68 – 77°F) and avoid excessive heat above 40°C (104°F).

What should I do if I am taking other medications?

Ask a doctor or pharmacist before using CVS Ibuprofen if you are taking other medications, especially if you are on blood thinners or have a history of stomach problems.

Packaging Info

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

CVS Ibuprofen Tablets USP contain 200 mg of ibuprofen per tablet. The product is identified by the National Drug Code (NDC) 51013-319-54. These tablets are formulated for oral administration and are indicated for the relief of pain and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently using anticoagulants or steroid medications

  • Are taking other NSAIDs, whether prescription or over-the-counter (including aspirin, ibuprofen, naproxen, or others)

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Monitoring and Discontinuation Healthcare professionals should advise patients to stop using ibuprofen and consult a physician if they experience any signs indicative of stomach bleeding, including:

  • Feeling faint

  • Vomiting blood

  • Noticing bloody or black stools

  • Experiencing stomach pain that does not improve

  • Having pain that worsens or persists beyond 10 days

  • Observing a fever that worsens or lasts more than 3 days

  • Noticing redness or swelling in the affected area

Additionally, any new or unusual symptoms should prompt a consultation with a healthcare provider.

Emergency Medical Help In cases of suspected overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Additionally, there is a warning regarding the potential for heart attack and stroke, which may occur with the use of NSAIDs, excluding aspirin. These cardiovascular events can be fatal, and the risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Other concerning symptoms include worsening pain lasting more than 10 days, fever persisting for more than 3 days, or the presence of redness or swelling in the painful area.

Before using this product, patients should seek medical advice if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended to consult a healthcare provider if the patient is taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Furthermore, patients under a doctor's care for any serious condition or those taking other medications should also seek guidance prior to use.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of these medications for individuals relying on aspirin for cardiovascular protection.

When ibuprofen is administered alongside anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding if these drugs are prescribed together.

Additionally, exceeding the recommended dosage or duration of ibuprofen therapy may elevate the risk of cardiovascular events, such as heart attack or stroke. It is essential to adhere to prescribed guidelines to mitigate these risks.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ibuprofen.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing and monitoring treatment in this population.

Additionally, the risk of heart attack or stroke may be elevated in geriatric patients who use the medication in excess of the recommended dosage or for durations longer than directed. It is essential for healthcare providers to closely monitor elderly patients for any signs of adverse effects and to ensure adherence to prescribed dosages to mitigate these risks.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted in these patients to ensure their safety while on treatment.

Overdosage

Overdosage of ibuprofen can result in significant health risks and requires prompt medical intervention.

Symptoms of Overdose Healthcare professionals should be aware that symptoms of ibuprofen overdose may manifest as nausea, vomiting, stomach pain, drowsiness, headache, and confusion. In more severe instances, the overdose may escalate to critical conditions such as kidney failure, liver damage, or gastrointestinal bleeding.

Recommended Actions In the event of a suspected overdose, it is imperative to seek immediate medical attention. Timely intervention is crucial to mitigate potential complications and ensure appropriate management of the patient's condition.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of serious adverse reactions associated with the use of the product. These include cardiovascular events such as heart attack and stroke. Gastrointestinal complications have been reported, including bleeding, ulceration, and perforation. Severe allergic reactions, such as anaphylaxis and angioedema, have also been documented.

Additionally, instances of liver injury have been noted, characterized by elevated liver enzymes and hepatitis. Renal toxicity has been reported, including cases of acute renal failure and interstitial nephritis. Skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed. Furthermore, hematologic reactions, including thrombocytopenia and aplastic anemia, have been identified in the postmarketing data.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after undergoing heart surgery.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if pain worsens or lasts more than 10 days, if fever intensifies or lasts more than 3 days, or if redness or swelling occurs in the painful area. Furthermore, patients should be encouraged to stop use and consult a doctor if any new symptoms arise.

When using this product, patients should be informed that taking it with food or milk may help alleviate any stomach upset. It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for a duration longer than directed.

Healthcare providers should recommend that patients consult a doctor before use if they have a history of problems or serious side effects related to pain relievers or fever reducers. Patients should also be advised to seek medical advice if the stomach bleeding warning is applicable to them, or if they have a history of stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should be encouraged to consult a doctor prior to use.

Patients taking diuretics or those under a doctor's care for any serious condition should also be advised to seek guidance before using this medication. Lastly, it is important to inform patients that they should consult a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. They should also be encouraged to discuss any other medications they are currently taking with their healthcare provider.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Ibuprofen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.